Efficacy and Safety of HRS-7535 Tablets in Adults With Diabetic Kidney Disease in Type 2 Diabetes

NCT ID: NCT06415214

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 281 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-21
• Study Completion Date: 2025-07-25

Brief Summary

The study is a 16-week multicenter, randomized, double-blind, placebo-controlled, parallel-designed Phase II clinical study. The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with diabetic kidney disease in type 2 diabetes.

Conditions

Diabetic Kidney Disease, Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A，Subjects will receive Placebo administered orally

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Group B，Subjects will receive HRS-7535 administered orally

Group Type: EXPERIMENTAL

HRS-7535

Intervention Type: DRUG

HRS-7535

Group C，Subjects will receive escalated HRS-7535 administered orally

Group Type: EXPERIMENTAL

HRS-7535

Intervention Type: DRUG

HRS-7535

Interventions

Placebo

Placebo

Intervention Type: DRUG

HRS-7535

HRS-7535

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects, 18-75 years of age at the time of signing informed consent;

2. Body weight ≥50 kg, 20.0 kg/m2 ≤BMI ≤40.0 kg/m2;

3. Diabetic kidney disease was diagnosed, and the eGFR≥30 mL/min/1.73 m2;

4. Had a history of T2DM at least 3 months, or had diabetic retinopathy as assessed by the investigators;

5. UACR ≥300 and <3000 mg/g;

6. HbA1c ≥6.5% and ≤10.0%;

7. ACEI/ARB was used for ≥3 months and ACEI/ARB was stabilized at either the maximum recommended dose (reference to the drug label) or the maximum tolerated dose within 4 weeks;

8. Use hypoglycemic drugs for ≥3 months (the dosage of SGLT2i remains stable if used);

9. Able and willing to provide a written informed consent;

Exclusion Criteria

1. Have type 1 diabetes mellitus or specific type of diabetes;

2. Acute kidney injury or dialysis treatment within 6 months;

3. Kidney transplantation is planned during the trial;

4. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;

5. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;

6. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;

7. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

HRS-7535-203

Identifier Type: -

Identifier Source: org_study_id